Catalog Number CLXECP |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot m128 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m128 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.At the time of this report, the analysis of the returned kit is still in process.A final report will be filed when the analysis is complete.(b)(4).H.M.(b)(6) 2024.
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Event Description
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The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported that during the treatment, the centrifuge bowl came out of the bowl holder and cracked the drive tube.The ecp treatment was aborted, and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer will return the kit for investigation.
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Manufacturer Narrative
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The customer returned the kit for evaluation.The smart card was not returned for evaluation.Examination of the centrifuge bowl showed signs of damage, indicating it had dislodged from the centrifuge bowl holder.Three out of four of the centrifuge bowl tabs were damaged and the bowl had scratches on the exterior.A pressure test was performed on the centrifuge bowl and drive tube and no leaks were detected.A known cause for the centrifuge bowl to dislodge out of the bowl holder is due to the centrifuge bowl not properly locked into the bowl holder during installation of the kit by the end user.A material trace of the bowl assembly and its components used to build lot m128 found no related non-conformances.The device history record (dhr) review did not identify any related non-conformances, deviations, or equipment maintenance events.This lot passed all lot release testing.The reported drive tube break was not verified during evaluation of the returned kit.However, the drive tube was found to be damaged.The damage to the drive tube is most likely due to the centrifuge bowl not being secured into the bowl holder during installation of the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4) on (b)(6) 2024.
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Search Alerts/Recalls
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